Comparison Between Auto CPAP and Fixed CPAP in Chinese Patients With OSA

March 27, 2006 updated by: Chinese University of Hong Kong

Comparison of Auto-Continuous Positive Airway Pressure Device(Auto-CPAP) With Conventional Fixed CPAP in Chinese Patients With Obstructive Sleep Apnea (OSA)

AutoCPAP would lead to better compliance than FixCPAP

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomized crossover cohort. Study subjects consisted of patients newly diagnosed with obstructive sleep apnea (OSA) confirmed with sleep study. All are CPAP naïve.

Randomization:

Arm 1: auto CPAP sleep study then auto CPAP for 2 months Arm 2: fixed CPAP titration then fixed CPAP for 2 months

Then switch over to the other arm

Trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Prince of Wales Hospital
      • Hong Kong, China
        • North District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All subjects should be CPAP naïve.
  • OSA confirmed with sleep study
  • Presence of daytime symptoms with excessive daytime sleepiness
  • Age between 18 to 65
  • RDI greater than 30
  • Agreed to participate in trial with informed consent signed

Exclusion Criteria:

  • Patients not suitable to nasal CPAP because of facial abnormality leading to poor mask fitting.
  • Patients with known COPD with type II failure
  • Patients with known heart failure.
  • Patients with predominant central sleep apnea.
  • Patients need bilevel positive airway pressure ventilation.
  • Patients refusing to participate the trial.
  • Patients have difficulty to follow up regularly.
  • patients with untreated or under treatment of hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare the compliance of auto-CPAP and fixed CPAP in terms of CPAP usage hours.
To compare the clinical efficacy of auto-CPAP and fixed CPAP in terms of pressure level to abolish OSA, Epworth sleepiness scale and quality of life questionnaire.
To compare patient acceptance of the different type of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: To K Wang, FHKCP, Prince of Wales Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

March 28, 2006

Last Update Submitted That Met QC Criteria

March 27, 2006

Last Verified

August 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2004.258-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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